An interventional study of Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) and Attentional Placebo Control in Mental Health Disorder, sponsored by University of Washington. Active, not recruiting at 16 sites in Mozambique. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
The purpose of this study is to test the effectiveness of a multicomponent implementation strategy entitled the Systems Analysis and Improvement Approach for mental health (SAIA-M) using a cluster randomized trial at the health facility level. SAIA-MH focuses on improving the mental health treatment cascade in primary outpatient mental healthcare. The mental health treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement.
This study will also assess the potential mechanisms by which the SAIA-MH implementation strategy works, or does not work, along with the cost and effectiveness of scaling-up SAIA-MH in Mozambique.
Due to a shortage of 1.2 million mental health (MH) workers across low- and middle-income countries (LMICs), academic and policy leaders have advocated scaling-up task-sharing to lower-level providers to close the mental health care gap, which exceeds 90% in many LMICs. While task-sharing may increase access to care, limited attention has been paid to quality of care provided by lower-level providers. Task-shared outpatient management of mental health in Mozambique has shown low rates of retention in care (40%), medication adherence (\<15%), and proportion of patients achieving function improvement (\<5%). Similarly high rates of loss-to-follow-up, poor adherence, and poor patient outcomes have been reported across other LMICs. To our knowledge, there are no evidence-based implementation strategies targeting optimization of the MH treatment cascade in low-resource settings. This is an urgent need for the field of MH care delivery globally.
The MH treatment cascade is a model that outlines the sequential, linked treatment steps that people with mental illness must navigate, from initial diagnosis to symptom/function improvement. Quality problems in one step of a treatment cascade can have non-linear and compounding impacts across the larger complex care system. Implementation strategies focused on only one step in a cascade can potentially contribute to unintended system bottlenecks and quality of care issues. By contrast, the "Systems Analysis and Improvement Approach (SAIA)" is a multicomponent implementation strategy focused on optimizing an entire treatment cascade. SAIA blends facilitation, enhanced local clinical consultation, and the creation of facility-level learning collaboratives with systems-engineering tools in a 5-step approach specifically developed for task-shared providers, which include: (1) cascade analysis to visualize treatment cascade drop-offs and prioritize areas for system improvements; (2) process mapping to identify modifiable facility-level bottlenecks; (3) identification and implementation of modifications to improve system performance; (4) assessment of modification effects on the cascade; and (5) repeated analysis and improvement cycles. A previous cluster RCT established effectiveness of SAIA for HIV treatment cascade improvement (R01HD075057; PI: Sherr). However, no effectiveness data exist on SAIA applied to other complex treatment cascades - such as task-shared MH care. Preliminary data suggest that applying SAIA to MH treatment cascade optimization (SAIA-MH; R21MH113691; PI: Wagenaar) is feasible, acceptable, and can result in clinically-significant treatment cascade improvements; Five months of SAIA-MH implementation resulted in a 1.5-fold increase in medication adherence (aOR: 1.5; CI: 1.2, 1.9) and a 3.7-fold increase in function improvement (aOR: 3.7; CI: 2.5, 5.4). These data suggest that SAIA-MH is a promising strategy for task-shared MH systems improvement globally. Our specific aims are to:
Primary Aim 1: Test the effectiveness of the SAIA-MH strategy using a pragmatic cluster RCT design and assess determinants of implementation success. The investigators will implement SAIA-MH using a 3-year parallel cluster RCT across 8 intervention and 8 attentional control facilities and evaluate effects on mental health function improvement (primary) and retention / medication adherence (secondary). Two years of study implementation will be followed by a 1-year maintenance phase to examine routine fidelity and sustainability. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success.
Secondary Aim 1: Test causal pathway models to analyze mechanisms of action for effects (or non-effects) of the SAIA-MH implementation strategy. Using 3-years of monthly data on strategy-mechanism linkages, moderators, preconditions, and outcomes for the full 8 intervention and 8 attentional control facilities, the investigators will examine causal pathway effect estimates using longitudinal structural equation modeling. Qualitative CFIR data from Primary Aim 1 will contextualize quantitative path analyses.
Specific Aim 2: Estimate the cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique. The investigators will conduct micro-costing and time-and-motion observation of the SAIA-MH RCT to estimate costs of implementing the intervention. The investigators will construct a Markov model parameterized with cost and outcome data from the SAIA-MH RCT to project budget impact and cost-effectiveness for SAIA-MH scale-up to provincial and national levels.
Inclusion Criteria for Primary and Secondary Outcomes:
1. Patient diagnosed with a mental health condition in outpatient primary care, prescribed a medication, and given a follow-up date.
Exclusion Criteria for Primary and Secondary Outcomes:
Inclusion Criteria for Qualitative Interviews:
Exclusion Criteria for Qualitative Interviews:
1. Health worker not involved in outpatient mental healthcare delivery. Health worker not employed by the Ministry of Health.
Those receiving SAIA-MH will attend a 1-week in-person training for facility learning collaboratives. Following the 1-week in-person training, SAIA-MH standard operating procedures will be implemented, including: (1) structured internal/external facilitation following tablet-based guides used in pilot study (1x per week first month; 2x per week for next two months; 1x per month for remainder); (2) facilitation in the 5-step SAIA-MH improvement process.
Behavioral: Systems Analysis and Improvement Approach for Mental Health (SAIA-MH)
Control facilities will mimic activities of the intervention group in time and contacts, but without the "active ingredient" of the SAIA-MH implementation strategy
Behavioral: Attentional Placebo Control
The 5 steps of SAIA-MH include: (1) cascade analysis to visualize treatment cascade drop-offs and prioritize areas for system improvements; (2) process mapping to identify modifiable facility-level bottlenecks; (3) identification and implementation of modifications to improve system performance; (4) assessment of modification effects on the cascade; and (5) repeated analysis and improvement cycles.
Facilities randomized to attentional placebo control will attend a 1-week in-person training which will include the same minimum staff above for SAIA-MH. This training will focus on reviewing data collection tools, ethics, mental health stigma and burnout for mental health professionals. Following the 1-week in person training, attentional placebo control facilities will receive regular supervision following the same schedule as SAIA-MH focused on reviewing data collection tools.
Patient Function Improvement
Patient function improvement is evaluated for all patients diagnosed with a mental disorder, prescribed a medication, given a follow-up date, and who return at least once. All patients diagnosed with a mental disorder in target clinics will have function improvement measured by the WHODAS 2.0 at each clinic visit. Improvement will be determined as patients with at least 1 follow-up visits who score less than 10 on the WHODAS 2.0 or have a 50% reduction in their baseline WHODAS 2.0 score.
Time frame: data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period
Patient Retention
Patient retention is evaluated for all patients diagnosed with a mental disorder, prescribed a medication, given a follow-up date, and who return at least once. This outcome evaluates whether these individuals returned for their scheduled follow-up visit in less than or equal to 30 days.
Time frame: data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period
Patient Medication Adherence
Medication adherence is evaluated for all patients diagnosed with a mental disorder, prescribed a medication, given a follow-up date, and who return at least once. These patients are considered to have potentially achieved medication adherence if they return for their follow-up visit and medication refill in less days than they had pills dispensed at their previous visit.
Time frame: data collection will occur over 6 months baseline, 24-month intervention and 12-month sustainment period
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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